Alka-seltzer

Patient Information Leaflet

Caution! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Alka-Seltzer (Alka-Zeltser)
324 mg, effervescent tablets
Acetylsalicylic acid
Alka-Seltzer and Alka-Zeltser are the same brand names of the same medicine written in Polish and Bulgarian respectively.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, consult your doctor.

Table of contents:

1. What Alka-Seltzer is and what it is used for
2. Important information before taking Alka-Seltzer
3. How to take Alka-Seltzer
4. Possible side effects
5. How to store Alka-Seltzer
6. Contents of the pack and other information

1. What Alka-Seltzer is and what it is used for

Acetylsalicylic acid, the active substance in Alka-Seltzer, has analgesic, anti-inflammatory, and antipyretic properties. Sodium citrate, formed when the tablet dissolves in water, has buffering properties and thus neutralizes excess hydrochloric acid in the stomach.
Indications:

• Mild to moderate pain, e.g.: headache, muscle pain (including general malaise), toothache
• Pain and fever associated with colds and influenza

2. Important information before using Alka-Seltzer

When not to use Alka-Seltzer

• if the patient is allergic to the active substance – acetylsalicylic acid, other salicylates, or any of the other components of this medicine (listed in section 6),
• if the patient has a bleeding tendency,
• if the patient has acute gastric or duodenal ulcer,
• if the patient has severe heart failure, severe liver failure, or severe renal failure,
• if the patient has previously experienced asthma attacks induced by salicylates or substances with similar action, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient is concurrently using methotrexate (used, among others, in cancer treatment) at doses of 15 mg per week or higher,
• if the patient is in the last trimester of pregnancy,
• in children under 12 years of age.

Warnings and precautions
Before starting to use Alka-Seltzer, consult a doctor or pharmacist:

• if the patient is hypersensitive to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• if the patient is concurrently using anticoagulant drugs,
• if the patient has impaired liver function,
• if the patient has kidney dysfunction or circulatory disorders (e.g. renal vascular disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney dysfunction and severe renal failure,
• if the patient has a history of (chronic or recurrent) peptic ulcer disease or gastrointestinal bleeding,
• if the patient suffers from a genetic disorder involving deficiency of the enzyme glucose-6-phosphate dehydrogenase, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Medicines containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary.
Acetylsalicylic acid may cause bronchospasm and provoke asthma attacks or other hypersensitivity reactions. Patients particularly at risk include those with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, and patients who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria).
Patients scheduled for surgical procedures (including minor procedures such as tooth extraction) should inform their doctor about taking Alka-Seltzer.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the drug may provoke an attack of gout.
Medicines containing acetylsalicylic acid should not be given to children and adolescents during viral infections (with or without fever) without consulting a doctor. During certain viral illnesses, particularly influenza A, influenza B, and varicella (chickenpox), there is a risk of developing Reye's syndrome – a rare but life-threatening condition requiring immediate medical attention.
The risk of Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered concurrently, although a causal relationship has not been proven. Persistent vomiting during an infection may indicate the onset of Reye's syndrome.
Prolonged use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Long-term use of analgesics, particularly those containing multiple active substances, may lead to serious kidney dysfunction and renal failure.

Alka-Seltzer and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for future use.
Particular caution is required when using Alka-Seltzer with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution;
• the effect of anticoagulants, thrombolytic drugs (clot-dissolving agents), and platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs (including other salicylates), or when alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a medicine used in heart conditions), as it increases its plasma concentration;
• the effect of antidiabetic medicines, e.g. insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressant medicines).

Particular caution is required when using Alka-Seltzer with the following medicines, as acetylsalicylic acid weakens their action:

• uricosuric agents used in the treatment of gout that increase the excretion of uric acid from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretics;
• certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors).

Alka-Seltzer may be used concurrently with the above-mentioned medicines (except methotrexate at doses of 15 mg per week or higher) only after consultation with a doctor.

Alka-Seltzer with food, drink, or alcohol
See section 3 of the leaflet.
Warning! Alcohol may increase the risk of adverse effects on the gastrointestinal tract, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and fertility

During pregnancy, breastfeeding, or when pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Alka-Seltzer during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart dysfunction in the unborn child. It may also affect the tendency of both mother and child to bleed and may delay or prolong labor.
Do not use Alka-Seltzer during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. If Alka-Seltzer is taken for longer than a few days beyond the 20th week of pregnancy, it may cause kidney dysfunction in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts.

Fertility
Alka-Seltzer belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

Alka-Seltzer contains sodium and sodium benzoate
One Alka-Seltzer tablet contains 477 mg of sodium (main component of table salt). This corresponds to 24% of the maximum recommended daily dietary sodium intake for adults.
The maximum daily dose of this product equals 288% of the WHO recommended maximum daily sodium intake.
The medicine contains 0.10 mg of sodium benzoate per dosage unit. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

3. How to use Alka-Seltzer

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.
If in doubt, consult a physician or pharmacist.
The recommended dose of Alka-Seltzer is:
Adults:
Single dose of 1 to 3 effervescent tablets (i.e. 324 to 972 mg of acetylsalicylic acid). If necessary, the single dose may be repeated after a minimum of 4 to 6 hours. Do not exceed 4000 mg of acetylsalicylic acid in 24 hours (i.e. a maximum of 12 effervescent tablets per day).
Adolescents over 12 years of age:
This medicine may be used in adolescents over 12 years of age only on medical advice.
Take 1 effervescent tablet (i.e. 324 mg of acetylsalicylic acid) as a single dose. If necessary, the single dose may be repeated up to 3 times daily, no more frequently than every 4–6 hours.
Do not take more than 3 effervescent tablets (i.e. 972 mg of acetylsalicylic acid) per day.
Use with caution in patients with impaired liver and/or kidney function.
Do not use this medicine for longer than 3–5 days without consulting a physician.
The tablets should be dissolved in a glass of water and the effervescent solution drunk. Take after meals.

Taking more Alka-Seltzer than recommended
Poisoning with the active substance in Alka-Seltzer may result from prolonged use (mild poisoning) or overdose (severe poisoning), which may be life-threatening, e.g. after accidental ingestion by children or elderly persons.
Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus, deafness, excessive sweating, nausea and vomiting, headache, confusion (disturbances of consciousness with disorientation, disturbances in thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual disturbances, fainting).
In severe poisoning, additional symptoms may include: high fever, respiratory disturbances (up to respiratory arrest and suffocation), disturbances in heart and blood vessel function (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced daily urine output below 400–500 ml in adults] up to kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, disturbances in blood coagulation, and neurological disturbances manifesting as lethargy, confusion up to coma, and convulsive seizures.
In case of overdose, seek immediate medical advice from a physician or pharmacist; in cases of severe poisoning, the patient must be taken immediately to hospital.
Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be required.

Missed dose of Alka-Seltzer
If a dose is missed and symptoms persist, take the next dose of Alka-Seltzer as scheduled. Do not take a double dose to make up for a missed dose.

Stopping Alka-Seltzer
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Warning:

• If frothy vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
• Signs of a severe hypersensitivity reaction may include: swelling of the face and eyelids, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. In case any of these symptoms occur, immediate professional medical care must be provided. These reactions may occur even after the first dose of the medicine.

The frequency of the possible adverse effects listed below is defined as follows: common (in more than 1 patient in 100 but less than 1 in 10), rare (in more than 1 patient in 10,000 but less than 1 in 1,000), very rare (in less than 1 patient in 10,000), unknown (frequency cannot be determined from available data).

Gastrointestinal disorders:
Common: Stomach and abdominal pain, heartburn, dyspepsia.
Rare: Inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (frothy vomiting, tarry stools) or occult (bleeding occurs more frequently with higher doses); peptic ulcer disease of the stomach or duodenum, perforation.
Unknown: Constrictive intestinal enteropathy (especially during long-term use), nausea, vomiting.

Hepatic and biliary disorders:
Very rare: Transient disturbances in liver function (increased aminotransferase activity).

Nervous system disorders:
Rare: Intracerebral haemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of other antithrombotic medicines), potentially life-threatening.
Unknown: Dizziness, usually symptoms of overdose.

Ear and labyrinth disorders:
Common: Tinnitus, usually symptoms of overdose.

Blood and lymphatic system disorders:
Unknown: Increased risk of bleeding, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia. Bleeding may result in iron deficiency anaemia or haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory test results. Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Vascular disorders:
Unknown: Haemorrhages (post-procedural, epistaxis, gingival, genitourinary), bruising.

Renal and urinary disorders:
Unknown: Impaired kidney function and severe kidney damage.

Immune system disorders:
Rare: Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings, such as mild to moderate reactions affecting the skin, respiratory system, cardiovascular system, with symptoms such as: rash, urticaria, angioedema (including vasomotor), rhinitis, nasal mucosal congestion.
Unknown: Severe reactions, including anaphylactic shock, breathing difficulties, and cardiac disturbances.

Respiratory, thoracic and mediastinal disorders:
Unknown: Respiratory system disease, which worsens after administration of acetylsalicylic acid.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows further information on the safety of the medicine to be collected.

5. How to store Alka-Seltzer

Store below 25ºC.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Alka-Seltzer contains
The active substance is acetylsalicylic acid (Acidum acetylsalicylicum).
Other components are: citric acid, sodium hydrogen carbonate, povidone K 25, a mixture of
dimethicon and calcium silicate, a mixture of sodium lauryl sulfate and sodium benzoate, sodium saccharin,
lime flavour, lemon flavour.

What Alka-Seltzer looks like and contents of the pack
One double sachet contains 2 effervescent tablets.
The cardboard pack contains 10 effervescent tablets in the form of 5 double sachets, each containing
2 effervescent tablets.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Bulgaria, the country of export:
Bayer Bulgaria EOOD
Blvd. Tsarigradsko Shose № 115 M, floor ground, 1784 Sofia, Bulgaria

Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee 1, 06803 Bitterfeld-Wolfen, Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Bulgaria (country of export) Marketing Authorisation Number: 20010171
Parallel Import Licence Number: 298/20